The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data, showing that initiation of TREMFYA® (guselkumab) was associated with greater treatment persistencea compared to secukinumab or ixekizumab in bio-naïve and bio-experienced patientsb living with moderate to severe plaque psoriasis (PsO), based on pairwise analysesc of real-world data.[1],[2] Additionally, in a post-hoc analysis of Phase 3 VOYAGE 2 clinical trial results, TREMFYA demonstrated durable clinical efficacy, itch relief and quality-of-life improvements in patients living with scalp PsO.[3] TREMFYA is the first and only fully human selective interleukin (IL)-23 inhibitor therapy approved in the U.S. for adults with moderate to severe plaque PsO.[4] These study results are among 14 company-sponsored abstracts being presented by Janssen at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, LA.
Analysis of real-world data from the IBM MarketScan Research Databases from July 13, 2017, to May 1, 2021, showed TREMFYA was associated with greater persistence (i.e., longer median time to index treatment discontinuation) compared to secukinumab and ixekizumab among bio-naïve patients:[1]
- The TREMFYA cohort showed 2.20 times (at 12 months) and 2.28 times (at 18 months) longer persistence versus the secukinumab cohort, and 1.84 times (at 12 months) and 1.86 times (at 18 months) longer persistence versus the ixekizumab cohort.[1]
- 2,202 and 2,772 patients were identified for pairwise analysis of the TREMFYA versus secukinumab cohorts, and 2,241 and 2,007 patients for pairwise analysis of the TREMFYA versus ixekizumab cohorts, respectively.[1]
Analysis of real-world data from the IBM MarketScan Research Databases from July 13, 2017, to May 1, 2021, showed TREMFYA was associated with greater persistence compared to secukinumab and ixekizumab among bio-experienced patients:[2]
- The TREMFYA cohort showed 2.00 times (at 12 months) and 2.04 times (at 18 months) longer persistence versus the secukinumab cohort, and 1.76 times (at 12 months) and 1.67 times (at 18 months) longer persistence versus the ixekizumab cohort.[2]
- 1,314 and 3,294 patients were identified for pairwise analysis of the TREMFYA and secukinumab cohorts, and 1,564 and 2,667 patients for pairwise analysis of the TREMFYA and ixekizumab cohorts, respectively.[2]
“These persistency real-world results potentially indicate that TREMFYA is associated with better long-term control of the symptoms associated with PsO compared with secukinumab and ixekizumab, irrespective of whether patients were bio-naïve or bio-experienced,” said Steven Feldman, M.D., Ph.D., dermatologist at the Wake Forest University School of Medicine.d “Increasing our understanding of real-world data can improve clinical practice, leading to benefits for our patients. These critical insights help us make better treatment decisions for, and with, our patients living with PsO.”
In a post-hoc analysise of the Phase 3 VOYAGE 2 clinical trial, which compared TREMFYA with placebo and with adalimumab in patients with moderate to severe plaque PsO, TREMFYA demonstrated durable clinical efficacy, changes in mean Psoriasis Symptoms and Signs Diary (PSSD) itch scoresf and quality-of-life improvements in adult patients with scalp PsO:[3]
- Among TREMFYA responders (patients achieving at least 90 percent improvement from baseline in Psoriasis Area and Severity Index [PASI 90] score)[3],g remaining on treatment, mean scalp-specific Investigator Global Assessment (ss-IGA)h score rapidly improved from 2.9 at week 0 to 0.2 at week 24, and 0.3 at week 48.[3]
- Changes in mean PSSD itch scores and Dermatology Life Quality Index scores paralleled changes in mean ss-IGA scores for all cohorts.[3]
“These new data underscore Janssen’s commitment to provide efficacious and long-lasting treatments for people living with PsO, which may also proactively contribute to their overall well-being,” said Lloyd Miller, M.D., Ph.D., Vice President, Immunodermatology Disease Area Stronghold, Janssen Research & Development, LLC. “Up to 80 percent of people living with PsO have scalp involvement, and it significantly impacts quality of life.[5] These results continue to show the important role TREMFYA plays in the management of moderate to severe plaque PsO, including difficult-to-treat areas such as the scalp.”
About VOYAGE 2 (NCT02207244; EudraCT 2014-000720-18)[9],[10]
This Phase 3, randomized, double-blind, placebo- and active comparator-controlled clinical trial was designed to evaluate the efficacy and safety of TREMFYA compared with placebo and adalimumab in adults with moderate to severe plaque PsO.9 Patients (N=992) were randomized to receive subcutaneous injections of TREMFYA 100 mg (n=496) at weeks 0, 4, and every 8 weeks (q8w) thereafter; placebo (n=248) at weeks 0, 4, and 12 followed by crossover to TREMFYA 100 mg at week 16; or adalimumab 80 mg (n=248) at week 0, 40 mg at week 1, then 40 mg every 2 weeks (q2w) until week 23.[11] Weeks 28-72 incorporated a randomized withdrawal study design.[11] During the open-label period (weeks 76-252), all patients received TREMFYA 100 mg q8w.9 Physician- and patient-reported outcomes were assessed.[11] Efficacy was analyzed using prespecified treatment failure rules (patients discontinuing due to lack of efficacy, worsening of PsO, or use of a prohibited treatment were considered non-responders).11 Data were combined for patients randomized to TREMFYA and for those originally randomized to placebo who later crossed over to TREMFYA at week 16.[11] Patients were treated and followed for up to 264 weeks.[9]
Co-primary endpoints of the study were proportions of patients receiving TREMFYA versus placebo achieving IGA 0/1 (clear/almost clear) (84 vs 9 percent, respectively [P<0.001 vs placebo]) and PASI 90 (70 vs 2 percent, respectively [P<0.001 versus placebo]) at week 16.11 Additional efficacy assessments included proportions of patients achieving PASI 75, and PASI 100 responses, as well as IGA score of 0, Dermatology Life Quality Index score of 0/1, PSSD score of 0, SF-36, the Hospital Anxiety and Depression Scale, and the Work Limitations Questionnaire.11 Efficacy was analyzed using pre-specified treatment failure rules, non-responder imputation, and as observed methodology.[11]
About Plaque Psoriasis (PsO)
Plaque PsO is an immune-mediated disease resulting in an overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.[12] It is estimated that eight million Americans and more than 125 million people worldwide live with the disease.[13] Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe.13 Living with plaque PsO can be a challenge and impact life beyond a person’s physical health, including emotional health, relationships, and handling the stressors of life.[14]
About TREMFYA® (guselkumab)4
Developed by Janssen, TREMFYA is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.[4],[15] IL-23 is an important driver of the pathogenesis of inflammatory diseases such as moderate to severe plaque PsO and active psoriatic arthritis (PsA).[4] TREMFYA is approved in the U.S., Canada, Japan, and a number of other countries worldwide for the treatment of adults with moderate to severe plaque PsO who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light), and for the treatment of adult patients with active PsA.[4],[16],[17] It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior conventional synthetic disease modifying antirheumatic drug therapy.[15] Guselkumab is being investigated in Phase 2/3 clinical trials in both adults with moderately to severely active Crohn’s disease (EudraCT 2017-002195-13) and adults with moderately to severely active ulcerative colitis (EudraCT 2018-004002-25).[18],[19]
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension.
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